ong-Term Prolonged-Release Fampridine Treatment and Quality of Life

Conditions: Multiple Sclerosis
MedDRA version: 14.1Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2011-003507-38-IT

Lead Sponsor: BIOGEN IDEC RESEARCH LTD

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 800

Inclusion Criteria

To be eligible to participate in this study, candidates must meet the following eligibility criteria at the Screening Visit or at the timepoint specified in the individual eligibility criterion listed: 1. Ability to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use protected health information (PHI) in accordance with national and local subject privacy regulations. 2. Male or female subjects, 18 to 75 years old, inclusive, at the time of informed consent. 3. Must have a diagnosis of primary-progressive, secondary-progressive, progressive-remitting, or relapsing-remitting MS per revised McDonald Committee criteria (Section 22.1 [Polman et al, 2011]) as defined by Lublin and Reingold [Lublin and Reingold 1996] of at least 3 months duration. 4. Have a walking impairment as determined by the Investigator. 5. Able to perform the T25FW (Section 22.2) test with or without a walking aid. 6. Female subjects of childbearing potential must practice effective contraception during the study and be willing and able to continue contraception for 30 days after their last dose of study treatment. 7. Able to understand and comply with the requirements of the protocol.
Are the trial subjects under 18? no
Number of subjects for this age range: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 640
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 160

Exclusion Criteria

Candidates will be excluded from study entry if any of the following exclusion criteria are met at the Screening Visit or at any time during the screening period, or at the timepoint specified in the individual eligibility criterion listed: Medical History 1. Known allergy to pyridine-containing substances or to any of the inactive ingredients (see Section 12.1) in the prolonged-release fampridine tablet. 2. Any history of seizure, epilepsy, or other convulsive disorder, with the exception of febrile seizures in childhood. 3. An estimated CrCl of <80 mL/minute. 4. Subject needs to take medicinal products that are inhibitors of organic cation transporter 2 (OCT2 [e.g., cimetidine]). Miscellaneous 5. Female subjects who are currently pregnant or who are considering becoming pregnant while participating in the study. Female subjects of childbearing potential who have a positive pregnancy test at the Screening Visit may not participate in this study. 6. Female subjects who are currently breastfeeding. 7. Previous exposure to fampridine.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: The primary objective of the study is to assess the effect of long-term treatment with prolonged-release fampridine 10 mg twice daily on the physical component scale (PCS) of the Short Form (36) Health Status Questionnaire (SF-36) as reported by treatment responders.;Secondary Objective: The secondary objectives of this study are as follows: 1) Compare the change in the PCS of the SF-36 between treatment responders and non-responders (treatment discontinued at Week 4). 2)Evaluate change from baseline in additional QoL measures among treatment responders as well as changes from baseline in treatment responders versus non-responders. 3)Assess the safety and tolerability of prolonged-release fampridine 10 mg twice daily.;Primary end point(s): Change from baseline in the PCS of the SF-36 measured over Months 3, 6, 9, and 12 among subjects who respond to treatment with prolongedrelease fampridine.;Timepoint(s) of evaluation of this end point: baseline and week 12, 24, 36, 48 and 50

Secondary Outcome Measures